Reattachment of a ligament to a bone in arthroscopic procedures such as, for example, repair of a torn rotator cuff typically involves two steps. First, an anchor is inserted into the bone. Then, the ligament is attached to the bone by passing a suture through the ligament tissue and then through the anchor, thereby tying the ligament to the bone.
There are several drawbacks to this method. First, two separate actions must be performed in order to attach the ligament to the bone, namely, insertion of the anchor into the bone and suturing of the ligament. The necessary involvement of at least two separate sets of tools inherently complicates the surgical procedure, when compared to performing the procedure while using a single tool.
In addition, placement of the anchor may require drilling into the bone, which creates debris that must be removed and can increase the stress on the bone. The procedures described above often require large access ports and/or open surgery to enable the positioning and actuation of the required tools.
Methods that do not require an anchor generally require creation of a plurality of bores in the bone. U.S. Pat. No. 6,523,417 discloses a method for suturing soft tissue to a bone in which a hole is drilled into the bone and a slit cut into it. PCT Pat. Application WO09/107121 discloses a method of suturing soft tissue to a bone in which two bores are made in the bone at an angle, preferably 70°. PCT Pat. Applications WO10/056785, WO10/056786, and WO10/056787 disclose suture anchoring systems in which two orthogonal bores are made in the bone. A major disadvantage of these methods is that the presence of a plurality of bores at an angle significantly weakens the bone, increasing the likelihood of later injury, fractures and eventually weakening of the bone. The main disadvantage in said publication is that these methods require highly invasive surgery in order to allow access and actuation of tools used in the procedure.
U.S. Pat. No. 6,328,744 discloses a bone suturing device in which a needle enters a bone at a non-perpendicular angle and a curved path due to the force exerted on the needle by a hinged handle. In preferred embodiments of the invention, a second needle is used as well and the bore created from two sides. While the purpose of the second needle is to increase the pressure used by the first needle to enter the bone rather than to push the bone away, the amount of stabilization actually performed by the second needle is limited because the two needles enter the bone from the same side. Thus. It is a long felt need to provide a device which will enable stabilization to said bone.
There is thus a long-felt need for a device that can enable direct attachment of the ligament and the bone by passing the suture through the bone without any need for a separate anchor or for weakening the bone by drilling two orthogonal holes through it and that supports the bone from a side other than that through which the needle enters.
Yet more, it is a further long-felt need for a device that can securely passes a suture so as to provide said attachment.
Yet more, it is a further long felt need to provide a tool that can be applied to the bone surface through a small minimally invasive incision and then be converted into a second larger profile, that enables fixation to a bone surface along the path of an arc within the bone without enlargement of the access incision point.